NCT00428987

Brief Summary

This study will describe the phenotype (physical and behavioral traits) of overweight and obese people. It will characterize the hormones, metabolism, food preferences, fitness and physical activity levels, sleep patterns and thought processes in people with and without weight problems. Genetic material will be collected for studies of the internal codes that influence body weight. People over 18 years of age from all weight categories (lean, overweight, obese) who are reasonably healthy may be eligible for this study. Participants undergo the following tests and procedures:

  • Physical exam, electrocardiogram, blood and urine tests, instructions for recording food intake for 7 days
  • Metabolic studies for menstruating women.
  • Resting metabolic rate to study how many calories the body burns at rest.
  • Mixed meal test to measure hormones such as insulin that regulate blood sugar.
  • Glucose tolerance test to determine how sensitive the body is to insulin.
  • 24-hour energy expenditure to measure the amount of oxygen breathed in and the amount of carbon dioxide breathed out.
  • Repeat 24-hour energy expenditure.
  • Diurnal blood sampling and temperature assessment to study the body s internal clock.
  • Air-displacement plethysmography (Bod Pod) to measure body composition.
  • Dual energy x-ray absortiometry (DEXA) to measure body fat and bone density.
  • Repeat Bod Pod and DEXA.
  • Anthropometric measurements and bioelectrical impedance to measure height, weight, and circumferences, skinfold thickness, fluid status and percentage body fat.
  • Bromide dilution to measure the amount of water not in cells in the body.
  • Doubly labeled water to measure the amount of calories burned in a 7-day period.
  • 24-hour diet reports.
  • Endothelial reactivity to measure how the blood vessels stretch or dilate for assessing cardiovascular health.
  • Treadmill or bicycle exercise capacity test.
  • Physical activity monitor.
  • Unicorder to detect any breathing difficulties that may interfere with sleep.
  • Fat and muscle biopsy to look for variations in gene expression in fat tissue and muscle.
  • Neurocognitive testing to check memory, decision-making, hand-eye coordination, and reasoning.
  • Evaluation of mood problems and assess personality type.
  • Evaluation to assess the quantity and quality of pain experienced.
  • Taste testing to determine the response to bitter, salty, sweet and sour substances.
  • Occupational therapy evaluation to explore the subject's adaptations, if any, for performing personal, social or professional activities; the subject's views on his or her weight, body size and shape, and strategies to control weight.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 30, 2007

Completed
1 month until next milestone

Study Start

First participant enrolled

March 8, 2007

Completed
Last Updated

April 13, 2026

Status Verified

April 9, 2026

First QC Date

January 27, 2007

Last Update Submit

April 10, 2026

Conditions

ObesityHealthy Volunteers

Keywords

Energy ExpenditureBody CompositionObesityMetabolismPhenotypeNatural HistoryMorbid ObesityOverweightHealthy Volunteer

Outcome Measures

Primary Outcomes (1)

  • Phenotype (physical and behavioral traits) of overweight and obese people

    The aim of this study is to extensively phenotype subjects with varying degrees of obesity, as well as those with rare adipose disorders such as multiple symmetric lipomatosis (Madelung s disease), Dercums disease (adiposis dolorosa) and lipedema; to assess their hormonal, metabolic, cognitive and behavioral traits.

    Two weeks

Study Arms (3)

lean

Normal weight men and women over the age of 18 years with BMI greater than 18.5 and less than 25, who are reasonably healthy

obese

Obese men and women over the age of 18 years with BMI greater than 30, who are reasonably healthy

overweight

Overweight men and women over the age of 18 years with BMI greater than 25 and less than 30, who are reasonably healthy

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

men and women 18 years old and over with BMI \> 30 BMI \> 25 and \< 30 BMI \> 18.5 and \< 25

You may qualify if:

  • Obese subjects:
  • Obese men and women over the age of 18 years
  • BMI \> 30
  • Overweight subjects:
  • Overweight men and women over the age of 18 years
  • BMI \> 25 and \< 30
  • Control subjects (may be matched for age, sex and years of education):
  • Normal weight men and women over the age of 18 years
  • BMI \> 18.5 and \< 25

You may not qualify if:

  • Patients with significant physical limitations that may preclude them from completing the majority of the tests in this study
  • Current unstable medical conditions including cardiac ischemia, severe respiratory insufficiency requiring oxygen therapy, hepatic or cardiac failure as assessed by history and physical exam
  • Any psychiatric condition that would preclude participation in the study
  • Patients unwilling or unable to give informed consent
  • Pregnant woman.
  • Previous history of obesity as an adolescent or adult
  • Current or past history of eating disorders such as anorexia nervosa or bulimia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Publications (10)

  • Adams KF, Schatzkin A, Harris TB, Kipnis V, Mouw T, Ballard-Barbash R, Hollenbeck A, Leitzmann MF. Overweight, obesity, and mortality in a large prospective cohort of persons 50 to 71 years old. N Engl J Med. 2006 Aug 24;355(8):763-78. doi: 10.1056/NEJMoa055643. Epub 2006 Aug 22.

    PMID: 16926275BACKGROUND

  • Calle EE, Rodriguez C, Walker-Thurmond K, Thun MJ. Overweight, obesity, and mortality from cancer in a prospectively studied cohort of U.S. adults. N Engl J Med. 2003 Apr 24;348(17):1625-38. doi: 10.1056/NEJMoa021423.

    PMID: 12711737BACKGROUND

  • Fontaine KR, Redden DT, Wang C, Westfall AO, Allison DB. Years of life lost due to obesity. JAMA. 2003 Jan 8;289(2):187-93. doi: 10.1001/jama.289.2.187.

    PMID: 12517229BACKGROUND

  • Meral R, Malandrino N, Walter M, Neidert AH, Muniyappa R, Oral EA, Brown RJ. Endogenous Leptin Concentrations Poorly Predict Metreleptin Response in Patients With Partial Lipodystrophy. J Clin Endocrinol Metab. 2022 Mar 24;107(4):e1739-e1751. doi: 10.1210/clinem/dgab760.

    PMID: 34677608DERIVED

  • Armiyaw L, Sarcone C, Fosam A, Muniyappa R. Increased beta-Cell Responsivity Independent of Insulin Sensitivity in Healthy African American Adults. J Clin Endocrinol Metab. 2020 Jul 1;105(7):e2429-38. doi: 10.1210/clinem/dgaa234.

    PMID: 32382759DERIVED

  • Fosam A, Sikder S, Abel BS, Tella SH, Walter MF, Mari A, Muniyappa R. Reduced Insulin Clearance and Insulin-Degrading Enzyme Activity Contribute to Hyperinsulinemia in African Americans. J Clin Endocrinol Metab. 2020 Apr 1;105(4):e1835-46. doi: 10.1210/clinem/dgaa070.

    PMID: 32052016DERIVED

  • Kassai A, Muniyappa R, Levenson AE, Walter MF, Abel BS, Ring M, Taylor SI, Biddinger SB, Skarulis MC, Gorden P, Brown RJ. Effect of Leptin Administration on Circulating Apolipoprotein CIII levels in Patients With Lipodystrophy. J Clin Endocrinol Metab. 2016 Apr;101(4):1790-7. doi: 10.1210/jc.2015-3891. Epub 2016 Feb 22.

    PMID: 26900642DERIVED

  • Muniyappa R, Noureldin R, Ouwerkerk R, Liu EY, Madan R, Abel BS, Mullins K, Walter MF, Skarulis MC, Gharib AM. Myocardial Fat Accumulation Is Independent of Measures of Insulin Sensitivity. J Clin Endocrinol Metab. 2015 Aug;100(8):3060-8. doi: 10.1210/jc.2015-1139. Epub 2015 May 28.

    PMID: 26020762DERIVED

  • Muniyappa R, Sable S, Ouwerkerk R, Mari A, Gharib AM, Walter M, Courville A, Hall G, Chen KY, Volkow ND, Kunos G, Huestis MA, Skarulis MC. Metabolic effects of chronic cannabis smoking. Diabetes Care. 2013 Aug;36(8):2415-22. doi: 10.2337/dc12-2303. Epub 2013 Mar 25.

    PMID: 23530011DERIVED

  • Heikens MJ, Gorbach AM, Eden HS, Savastano DM, Chen KY, Skarulis MC, Yanovski JA. Core body temperature in obesity. Am J Clin Nutr. 2011 May;93(5):963-7. doi: 10.3945/ajcn.110.006270. Epub 2011 Mar 2.

    PMID: 21367952DERIVED

Related Links

MeSH Terms

Conditions

ObesityObesity, MorbidOverweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ranganath Muniyappa, M.D.

    National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Antoinette C Rabel, C.R.N.P.

CONTACT

(301) 451-8893rabela@mail.nih.gov

Ranganath Muniyappa, M.D.

CONTACT

(301) 451-7702muniyapr@mail.nih.gov

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2007

First Posted

January 30, 2007

Study Start

March 8, 2007

Last Updated

April 13, 2026

Record last verified: 2026-04-09

Locations

US(1)